Drug product
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
D-0952-2016
Product summary
- Event
- Event 73830
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7908 vials
- Official record key
drug-enforcement:D-0952-2016
Official wording
Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Code information: Lot #: a) C500006, Exp 11/17; b) C500001, Exp 11/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations